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Arrow

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
Device Name
Arrow-Karlan Introducer Laparoscopic Cholangiography Set with Karlan Balloon Catheter FDA UDI
Model / Reference
IPN917305 FDA UDI
Description
Arrow-Karlan Introducer Laparoscopic Cholangiography Set with Karlan Balloon Catheter FDA UDI

Identifiers

Catalog Number
CS-01700 FDA UDI
Primary DI / UDI-DI
10801902170177 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
ERCP catheter, non-balloon, non-electrical, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: ERCP catheter, non-balloon, non-electrical, single-use

Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ERCP catheter, non-balloon, non-electrical, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 37cfeb64-15f7-4f0c-b011-385d1949bbaf 35 fields · synced Jun 8, 2026